Duns Number:040729840
Device Description: Mictec Scissors Straight Squeeze Handle With Clean Flush Port
Catalog Number
-
Brand Name
Scissors
Version/Model Number
27995-01SH
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152400
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
fc75bb4c-b025-4e3c-bca8-546dff1234de
Public Version Date
July 02, 2020
Public Version Number
1
DI Record Publish Date
June 24, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |